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Results For "regulatory"

1839 News Found

FDA grants priority review to Daiichi Sankyo & Merck’s lung cancer drug application
Drug Approval | April 15, 2026

FDA grants priority review to Daiichi Sankyo & Merck’s lung cancer drug application

The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck


MSN Laboratories launches SEMABEST, India-made semaglutide pen at nearly 50% lower price
Drug Approval | April 15, 2026

MSN Laboratories launches SEMABEST, India-made semaglutide pen at nearly 50% lower price

CDSCO-approved therapy enters India’s fast-growing post-patent GLP-1 market with fully integrated API, formulation and pen manufacturing


MedLern partners with Godrej Memorial Hospital to strengthen accreditation-led workforce training
Hospitals | April 15, 2026

MedLern partners with Godrej Memorial Hospital to strengthen accreditation-led workforce training

Collaboration aims to align hospital staff learning with NABH 6th Edition standards, patient safety, and measurable quality outcomes


Boehringer Ingelheim & BioNTech launch high-stakes lung cancer combo trial
Clinical Trials | April 14, 2026

Boehringer Ingelheim & BioNTech launch high-stakes lung cancer combo trial

BioNTech will supply pumitamig, a PD-L1/VEGF-A bispecific antibody co-developed with Bristol Myers Squibb, while Boehringer Ingelheim will act as the regulatory sponsor of a Phase Ib/II study


Thermo Fisher and Singapore’s PRECISE launch major proteomics push in 100,000-person study
News | April 14, 2026

Thermo Fisher and Singapore’s PRECISE launch major proteomics push in 100,000-person study

The study’s multi-technology design is intended to improve reproducibility, strengthen regulatory-grade evidence generation


CDSCO reforms cut trial approval timelines by over 50%: DCGI Dr Rajeev Raghuvanshi
Drug Approval | April 14, 2026

CDSCO reforms cut trial approval timelines by over 50%: DCGI Dr Rajeev Raghuvanshi

Outlines 1,500-member internal cadre, digital regulatory system, and faster SEC-led reviews


India Pharma 2026 showcases sectoral transformation through four key plenary discussions
Policy | April 14, 2026

India Pharma 2026 showcases sectoral transformation through four key plenary discussions

Policy, regulations, AI and CRDMO take centre stage at the flagship event of the Department of Pharmaceuticals


India must build its own agile biopharma innovation model: ICMR DG Dr Rajiv Bahl
Policy | April 14, 2026

India must build its own agile biopharma innovation model: ICMR DG Dr Rajiv Bahl

At India Pharma 2026, Dr Bahl calls for experimentation over imitation as funding rises and translational ecosystem reforms gather pace


Gennova CEO Dr Sanjay Singh sees strong innovation momentum for India’s biopharma sector
Biopharma | April 14, 2026

Gennova CEO Dr Sanjay Singh sees strong innovation momentum for India’s biopharma sector

Veteran biopharma leader stressed that generic medicines must be viewed separately from biologics


Shalby Hospitals gets 5-year kidney transplant approval for Ahmedabad Krishna Unit
Hospitals | April 14, 2026

Shalby Hospitals gets 5-year kidney transplant approval for Ahmedabad Krishna Unit

The license is valid for five years, effective from April 9, 2026